Guideline for reporting systematic reviews of outcome measurement instruments (OMIs): PRISMA-COSMIN for OMIs 2024

Purpose Although comprehensive and widespread guidelines on how to conduct systematic reviews of outcome measurement instruments (OMIs) exist, for example from the COSMIN (COnsensus-based Standards for the selection of health Measurement INstruments) initiative, key information is often missing in published reports. This article describes the development of an extension of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 guideline: PRISMA-COSMIN for OMIs 2024. Methods The development process followed the Enhancing the QUAlity and Transparency Of health Research (EQUATOR) guidelines and included a literature search, expert consultations, a Delphi study, a hybrid workgroup meeting, pilot testing, and an end-of-project meeting, with integrated patient/public involvement. Results From the literature and expert consultation, 49 potentially relevant reporting items were identified. Round 1 of the Delphi study was completed by 103 panelists, whereas round 2 and 3 were completed by 78 panelists. After 3 rounds, agreement (≥ 67%) on inclusion and wording was reached for 44 items. Eleven items without consensus for inclusion and/or wording were discussed at a workgroup meeting attended by 24 participants. Agreement was reached for the inclusion and wording of 10 items, and the deletion of 1 item. Pilot testing with 65 authors of OMI systematic reviews further improved the guideline through minor changes in wording and structure, finalized during the end-of-project meeting. The final checklist to facilitate the reporting of full systematic review reports contains 54 (sub)items addressing the review’s title, abstract, plain language summary, open science, introduction, methods, results, and discussion. Thirteen items pertaining to the title and abstract are also included in a separate abstract checklist, guiding authors in reporting for example conference abstracts. Conclusion PRISMA-COSMIN for OMIs 2024 consists of two checklists (full reports; abstracts), their corresponding explanation and elaboration documents detailing the rationale and examples for each item, and a data flow diagram. PRISMA-COSMIN for OMIs 2024 can improve the reporting of systematic reviews of OMIs, fostering their reproducibility and allowing end-users to appraise the quality of OMIs and select the most appropriate OMI for a specific application. Note In order to encourage its wide dissemination this article is freely accessible on the web sites of the journals: Health and Quality of Life Outcomes; Journal of Clinical Epidemiology; Journal of Patient-Reported Outcomes; Quality of Life Research. Supplementary Information The online version contains supplementary material available at 10.1186/s12955-024-02256-9.


Objectives
2.2 Provide an explicit statement of the main objective(s) or question(s) the review addresses.
Provide an explicit statement of the main objective(s) or question(s) the review addresses.

96% consensus for inclusion
Consensus on inclusion obtained in Round 2.
Information sources 2.4 Specify the information sources (e.g.databases, registers) used to identify studies and the date when each was last searched.
Specify the information sources (e.g.databases, registers) used to identify studies and the date when each was last searched.

92% consensus for inclusion 96% consensus for wording
Consensus on inclusion obtained in Round 2.
Risk of bias 2.5 Specify the methods used to assess risk of bias in the included studies.
Specify the methods used to assess risk of bias in the included studies.

88% consensus for inclusion 92% consensus for wording
Consensus on inclusion obtained in Round 2. Specify the methods used to present and synthesize results.

87% consensus for inclusion 92% consensus for wording
Consensus on inclusion obtained in Round 2.

Included studies 2.7
Give the total number of included studies and participants and summarize relevant characteristics of studies.
Give the total number of included outcome measurement instruments and reports.

95% consensus for inclusion 87% consensus for wording
Give the total number of included outcome measurement instruments and reports.

98% consensus for inclusion 91% consensus for wording
Consensus on inclusion obtained in Round 3. Provide a general interpretation of the results and important implications.

100% consensus for inclusion 97% consensus for wording
Consensus on inclusion obtained in Round 2.

OTHER
Funding 2.11 Specify the primary source of funding for the review.
Specify the primary source of funding for the review.

92% consensus for inclusion 96% consensus for wording
Consensus on inclusion obtained in Round 2.

Rationale 3
Describe the rationale for the review in the context of existing knowledge.
Describe the rationale for the review in the context of existing knowledge.

98% consensus for inclusion 98% consensus for wording
Consensus on inclusion obtained in Round 1.

93% consensus for inclusion 92% consensus for wording
Specify, with citations, the methodology and/or guidelines used to conduct and report the systematic review.

92% consensus for inclusion 95% consensus for wording
Specify, with citations, the methodology and/or guidelines used to conduct the systematic review.

98% consensus for inclusion 98% consensus for wording
Consensus on inclusion obtained in Round 3.
Eligibility criteria 5 Specify the inclusion and exclusion criteria for the review and how studies were grouped for the syntheses.
Specify the inclusion and exclusion criteria for the review.

92% consensus for inclusion 92% consensus for wording
Consensus on inclusion obtained in Round 1.

97% consensus for inclusion 95% consensus for wording
Specify the methods used to collect data from reports, including how many reviewers collected data from each report, whether they worked independently any processes for obtaining or confirming data from study investigators, and if applicable, details of automation tools used in the process.

97% consensus for inclusion 90% consensus for wording
Consensus on inclusion obtained in Round 3.

Data items 10a
List and define all outcomes for which data were sought.Specify whether all results that were compatible with each outcome domain in each study were sought (e.g. for all measures, time points, analyses),

93% consensus for deletion
Consensus on deletion obtained in Round 1: Item deleted.

Synthesis methods 13a
Describe the processes used to decide which studies were eligible for each synthesis (e.g.tabulating the study intervention characteristics and comparing against the planned groups for each synthesis (item #5)).
Describe the processes used to decide which studies were eligible for summarizing or pooling the results.
[For content validity:] Describe the processes used to decide which results can be extrapolated from one instrument to other instruments.

82% consensus for inclusion 66% consensus for wording
Describe the processes used to decide which studies per measurement property were eligible for each synthesis.

89% consensus for inclusion 82% consensus for wording
Describe the processes used to decide which studies were eligible for each synthesis of each measurement property.

97% consensus for inclusion 90% consensus for wording
Describe the processes used to decide which studies were eligible for each synthesis.

90% consensus for inclusion 87% consensus for wording
Describe any methods used to explore possible causes of inconsistency among study results (e.g.subgroup analysis).

94% consensus for inclusion 88% consensus for wording
Consensus on inclusion obtained in Round 2.
13f Describe any sensitivity analyses conducted to assess robustness of the synthesized results.
Describe any subgroup analyses if conducted.

88% consensus for inclusion 89% consensus for wording
Describe any sensitivity analyses conducted to assess robustness of the synthesized results.

79% consensus for inclusion 78% consensus for wording
If applicable, describe any sensitivity analyses conducted to assess robustness of the synthesized results.

91% consensus for inclusion 94% consensus for wording
Consensus on inclusion obtained in Round 3.

83% consensus for inclusion 77% consensus for wording
Describe any methods used to assess certainty (or confidence) in the body of evidence for each measurement property for each outcome measurement instrument.Describe how many reviewers graded the evidence, whether they worked independently and, if so, how discrepancies were resolved.

91% consensus for inclusion 87% consensus for wording
Describe any methods used to assess certainty (or confidence) in the body of evidence for each measurement property of each outcome measurement instrument.

95% consensus for inclusion 91% consensus for wording
Describe any methods used to assess certainty (or confidence) in the body of evidence.
Formulating recommendations PC4 Describe any methods used to formulate recommendations and provide a rationale for the choice(s).

79% consensus for inclusion 83% consensus for wording
Describe any methods used to formulate recommendations on the most suitable outcome measurement instrument for a given purpose and provide a rationale for the choice(s).

85% consensus for inclusion
If applicable, describe any methods used to formulate recommendations regarding suitable outcome measurement instruments for a particular use.

91% consensus for inclusion
If

95% consensus for inclusion 90% consensus for wording
Describe the results of the search and selection process, from the number of records identified in the search to the number of records included in the review, ideally using a flow diagram.If applicable, also report the final number of outcome measurement instrument(s) included.

96% consensus for inclusion 91% consensus for wording
Describe the results of the search and selection process, from the number of records identified in the search to the number of reports included in the review, ideally using a flow diagram.If applicable, also report the final number of outcome measurement instrument(s) included.

99% consensus for inclusion 90% consensus for wording
Describe the results of the search and selection process, from the number of records identified in the search to the number of reports included in the review, ideally using a flow diagram.If applicable, also report the final number of outcome measurement instrument(s) included and the number of reports relevant to each instrument. 16b Cite studies that might appear to meet the inclusion criteria, but which were excluded, and explain why they were excluded.
Cite articles that might appear to meet the inclusion criteria, but which were excluded, and explain why they were excluded.

85% consensus for inclusion 88% consensus for wording
Not applicable -Will be clear from the flow diagram

90% consensus for deletion
Cite reports that might appear to meet the inclusion criteria, but which were excluded, and explain why they were excluded.

71% consensus for inclusion 81% consensus for wording
Consensus on inclusion obtained in workgroup meeting.

Outcome measurement PC5 [If multiple outcome measurement
Cite the first report on each included outcome

Present characteristics of each included
Consensus on inclusion obtained in Round 3.

Study characteristics 17
Cite each included study and present its characteristics.
Cite each included article on a measurement property and present its population characteristics.

90% consensus for inclusion 83% consensus for wording
Cite each included report evaluating one or more measurement property(ies) and present sample characteristics for each measurement property evaluated.

96% consensus for inclusion 90% consensus for wording
Cite each included report evaluating one or more measurement property(ies) and present sample characteristics.

99% consensus for inclusion 95% consensus for wording
Consensus on inclusion obtained in Round 3.

Risk of bias in studies 18
Present assessments of risk of bias for each included study.

91% consensus for inclusion 86% consensus for wording
For all measurement properties, present, for each study: (a) the reported result and (b) the rating against quality criteria, ideally using structured tables or plots.

97% consensus for inclusion 94% consensus for wording
Consensus on inclusion obtained in Round 2.

Results of syntheses 20a
For each synthesis, briefly summarise the characteristics and risk of bias among contributing studies.
[ Present results of all sensitivity analyses conducted to assess the robustness of the synthesized results.
Present results of all subgroup analyses if conducted.

93% consensus for inclusion 94% consensus for wording
Present results of all sensitivity analyses conducted to assess the robustness of the synthesized results.

79% consensus for inclusion 75% consensus for wording
If applicable, present results of all sensitivity analyses conducted to assess the robustness of the synthesized results.

91% consensus for inclusion 95% consensus for wording
Consensus on inclusion obtained in Round 3. Discuss any limitations of the evidence included in the review.
Discuss any limitations of the evidence included in the review.

96% consensus for inclusion 97% consensus for wording
Consensus on inclusion obtained in Round 1.
23c Discuss any limitations of the review processes used.
Discuss any limitations of the review processes used.

98% consensus for inclusion 96% consensus for wording
Consensus on inclusion obtained in Round 1.
23d Discuss implications of the results for practice, policy, and future research.
Discuss implications of the results for practice, policy, and future research.

96% consensus for inclusion 96% consensus for wording
Consensus on inclusion obtained in Round 1.